Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, to be used as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019 to be used in combination with an oral antidepressant, Spravato was intended for patients whose symptoms did not improve with two or more antidepressants.
Close to 30 percent of the estimated 280 million people worldwide living with major depressive disorder have treatment-resistant depression, according to Johnson & Johnson.
“Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” said Johnson & Johnson’s head of neuroscience, Bill Martin, in a press release.
The application includes data from a late-stage clinical trial that showed Spravato, as a standalone treatment, helped ease patients’ symptoms as early as 24 hours after treatment and continued to provide relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a healthcare setting. Unlike other antidepressants that regulate chemicals like serotonin and dopamine, Spravato works by boosting glutamate in the brain. Glutamate is the most abundant neurotransmitter in the brain and helps neurons communicate with each other.
Sales of Spravato surged 60% to $271 million in the three months ended June 30, compared with the same period in 2023. Spravato has been used by 100,000 people in 77 countries, according to Johnson & Johnson.